Study identification

EU PAS number

EUPAS35766

Study ID

40159

Official title and acronym

Physicians’ knowledge on the risks associated with Odomzo® exposure after the implementation of a risk minimization program (CLDE225A2405)

DARWIN EU® study

No

Study countries

France
Germany
Italy
Spain

Study description

Physicians’ knowledge on the risks associated with Odomzo® exposure after the implementation of a risk minimization program In order to minimize the risks associated with sonidegib exposure, Sun Pharma is implementing a pregnancy prevention program (PPP) as an additional risk minimization measure (aRMM) to reduce the likelihood that women of childbearing potential become pregnant while taking sonidegib, are prescribed sonidegib during pregnancy, or are exposed to sonidegib during pregnancy by their male partners while they are being treated. In addition, information about the potential effect of sonidegib on fertility is also included in the educational materials. The PPP consists of educational materials that comprise a Dear Healthcare Professional (DHCP) letter and separate HCP and patient educational brochures integrated with reminder cards. The DHCP letter, HCP brochure and copies of the Patient brochures will all be distributed at launch. HCPs should obtain additional patient educational materials as required from their local Sun Pharma representative. Furthermore, new prescribers will obtain copies of the educational materials from their local Sun Pharma representative. The effectiveness of the Odomzo® PPP will be measured on a country-specific level, in agreement with National Competent Authorities. This non-interventional study is a physician survey on their knowledge of the risks associated with sonidegib. It will be run in countries where surveys are considered an appropriate way to measure the effectiveness of the Odomzo® PPP, and is pending the agreement from National Competent Authorities. Participation in this study is optional for each country, and countries may implement alternative measures to assess the effectiveness of the Odomzo® PPP.

Study status

Planned

Contact details

Roxana Dragusel

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sun Pharmaceutical Industries Europe BV
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)